The primary objective of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Fluzoparib.
The secondary objective of the study was to assess the safety of Fluzoparib given alone versus Fluzoparib coadministered with Rifampicin.
Condition or disease | Intervention/treatment | Phase |
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Healthy Male Subjects | Drug: Fluzoparib Drug: Rifampicin | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Fluzoparib in Healthy Male Subjects |
Actual Study Start Date : | July 24, 2019 |
Actual Primary Completion Date : | September 16, 2019 |
Actual Study Completion Date : | September 16, 2019 |
Arm | Intervention/treatment |
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Experimental: Rifampicin + Fluzoparib |
Drug: Fluzoparib
single dose on Day 1 and Day 12
Drug: Rifampicin QD on Day 5-14 for 10 days
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
China, Zhejiang | |
First Affiliated Hospital of Zhejiang University School of Medicine | |
Hangzhou, Zhejiang, China, 310003 |
Tracking Information | |||||
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First Submitted Date ICMJE | July 3, 2019 | ||||
First Posted Date ICMJE | July 8, 2019 | ||||
Last Update Posted Date | February 26, 2020 | ||||
Actual Study Start Date ICMJE | July 24, 2019 | ||||
Actual Primary Completion Date | September 16, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Day 22 ] Laboratory indicators, 12-lead electrocardiogram (ECG), physical examination, vital signs, adverse events (NCI-CTC AE 5.0), etc.
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | A Drug-drug Interaction Trial of Rifampicin Pharmacokinetics Effect on Fluzoparib | ||||
Official Title ICMJE | A Single Center, Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Rifampicin on Fluzoparib in Healthy Male Subjects | ||||
Brief Summary |
The primary objective of the study was to assess the effect of repeated oral doses of Rifampicin on the pharmacokinetic profile of a single dose of Fluzoparib. The secondary objective of the study was to assess the safety of Fluzoparib given alone versus Fluzoparib coadministered with Rifampicin. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 1 | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Healthy Male Subjects | ||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Rifampicin + Fluzoparib
Interventions:
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Publications * | Zhang Q, Kai J, Zhai Y, Xu N, Shentu J, Zhang Y, Liang Y, Wang Y, Wu L. The impact of rifampicin on the pharmacokinetics of fuzuloparib in healthy Chinese male volunteers. Br J Clin Pharmacol. 2021 May 25. doi: 10.1111/bcp.14926. [Epub ahead of print] | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
16 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Actual Study Completion Date ICMJE | September 16, 2019 | ||||
Actual Primary Completion Date | September 16, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers ICMJE | Yes | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | China | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04011124 | ||||
Other Study ID Numbers ICMJE | FZPL-I-110 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | Jiangsu HengRui Medicine Co., Ltd. | ||||
Study Sponsor ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE | Not Provided | ||||
PRS Account | Jiangsu HengRui Medicine Co., Ltd. | ||||
Verification Date | February 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |